Behavioral Intervention for Obesity

(SWIFT Trial)

Overseen By Katherine Darling, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: GLP-1 receptor agonists

Disqualifiers: Cognitive impairment, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to tackle weight stigma and self-criticism in teens with obesity through a new program called Weight Bias Internalization. It tests whether addressing these issues can improve both physical and mental health outcomes. Participants will be randomly assigned to one of two groups: one group will focus on reducing weight stigma for 4 weeks before a 16-week weight management program, while the other group will start with general health topics before the same weight management program. The trial seeks adolescents aged 13-17 with a higher body weight (BMI above the 95th percentile) who can attend sessions with a caregiver. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could transform weight management and mental health support for teens.

Will I have to stop taking my current medications?

The trial requires that participants do not currently use glucagon-like peptide-1 (GLP-1) receptor agonists. Other medications are not mentioned, so it's unclear if you need to stop taking them.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that negative feelings about one's weight can lead to both physical and mental health problems. Studies have explored how addressing these feelings might improve health, especially for individuals with obesity.

One study examined the effects of cognitive behavioral therapy (CBT) on participants over six months. The results indicated that this approach was well-received, with no serious side effects. This therapy helps change negative thought patterns, reducing harmful feelings about weight and their effects.

Although direct evidence about the safety of the specific method used in this trial is lacking, similar studies have not reported harmful effects, suggesting it is generally safe. Additionally, this trial includes a standard weight management program, known to be safe and effective for teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Obesity trial because it tackles weight bias internalization (WBI), a relatively unexplored aspect of obesity treatment. Traditional obesity treatments often focus solely on diet and exercise. However, this trial's unique approach combines behavioral weight management with addressing internalized weight bias, potentially leading to better mental and physical health outcomes. By incorporating sessions that directly target weight stigma and WBI, participants might experience improved self-esteem and motivation, making it a promising new avenue in obesity management.

What evidence suggests that this trial's interventions could be effective for addressing weight bias internalization and weight management in adolescents?

This trial compares two approaches to addressing weight bias internalization and weight management in adolescents. Research has shown that negative feelings about one's weight can lead to mental health issues such as depression, anxiety, and low self-esteem. The "Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)" arm of this trial addresses these feelings to improve overall well-being. Studies have found that psychological support for these feelings can reduce their negative effects. In contrast, the "Health Information Control + Behavioral Weight Management Intervention (HIC + BWM)" arm initially focuses on health promotion for other adolescent health concerns. By addressing these feelings and providing proven weight management advice, the program aims to help teenagers live healthier lives and improve their mental health. ^{6 7 8 9 10}

Who Is on the Research Team?

Katherine Darling, PhD

Principal Investigator

The Miriam Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents aged 13-17 who are dealing with obesity and may experience weight discrimination. They should be interested in managing their weight and willing to participate in a program that includes discussions on weight stigma. Specific eligibility criteria were not provided, so additional factors may apply.

Inclusion Criteria

I am between 13 and 17 years old.

Have at least one caregiver available to provide consent and participate in sessions

Agree to study participation

Exclusion Criteria

I have cognitive issues that make group activities difficult.

Medical condition known to impact weight or that would otherwise prevent participation

Current participation in a weight management program or recent weight loss of 5% of body weight or more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a 4-week intervention focused on weight stigma and WBI or a health information control, followed by a 16-week behavioral weight management program

20 weeks

20 weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Weight Bias Internalization

Trial Overview The study tests a new approach combining an intervention addressing weight stigma and internalization with a behavioral weight management program. Participants will either receive this combined intervention or just the weight management program after attending health information sessions unrelated to weight.

How Is the Trial Designed?

Group I: Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM) Experimental Treatment 2 Interventions

WBI+BWM is a multicomponent behavioral weight loss intervention designed to address both weight bias internalization and weight status in adolescents. The first four sessions of the intervention will be focused on targeted WBI/weight stigma content, followed by 16 sessions addressing both weight stigma/WBI and evidence-based weight management strategies. Weekly meetings are scheduled for 75 minutes and are facilitated by a behavioral expert (e.g., PhD in clinical psychology). Caregivers attend 4 of the 20 weekly groups with their teens.

Group II: Health Information Control + Behavioral Weight Management Intervention (HIC + BWM) Active Control 1 Intervention

The first four sessions (weeks 1-4) of the HIC+BWM group will focus on health promotion for adolescent health concerns other than weight management (e.g., skin cancer prevention, smoking cessation). This health information control will allow for testing of the initial 4- week WBI intervention as compared to a contact-matched control. Following the four-week health education control, the remaining 16 sessions will focus on evidence-based weight management strategies. Caregivers attend 4 of the 20 weekly groups with their teens.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

Published Research Related to This Trial

Weight bias internalization is significantly associated with poorer psychosocial, physical, and behavioral health outcomes, as shown in a meta-analysis of 149 studies involving nearly 18,800 participants.

Individuals with higher weight bias internalization experience worse mental health and are less likely to achieve weight loss, highlighting the need for targeted interventions to address this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Bias Internalization and Psychosocial, Physical, and Behavioral Health: A Meta-Analysis of Cross-Sectional and Prospective Associations. Romano, KA., Heron, KE., Sandoval, CM., et al.[2023]

In a study of 18,769 adults in a commercial weight management program, weight bias internalization (WBI) was found to be relatively high, indicating that many individuals internalize negative societal attitudes about weight, with an average WBIS-M score of 4.3.

WBI was notably higher among younger, female participants with higher BMIs, while it was lower in Black individuals and those with romantic partners, suggesting that demographic factors and the timing of weight stigma experiences play a significant role in WBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight bias internalization in a commercial weight management sample: prevalence and correlates. Pearl, RL., Himmelstein, MS., Puhl, RM., et al.[2023]

Obese patients with binge eating disorder (BED) show significantly higher levels of internalized weight bias (IWB) compared to overweight individuals in the general population, indicating a strong impact of societal bias on this group.

IWB is closely linked to more severe eating disorder symptoms, fat phobia, and depression, while negatively affecting self-esteem, suggesting that addressing IWB could be crucial in treating BED effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internalized weight bias in obese patients with binge eating disorder: associations with eating disturbances and psychological functioning. Durso, LE., Latner, JD., White, MA., et al.[2022]

The Weight Bias Internalization Scale (WBIS) was developed and validated as a reliable tool to measure internalized weight bias among overweight and obese individuals, showing high internal consistency (Cronbach's alpha = 0.90).

Internalized weight bias, as measured by the WBIS, significantly correlates with negative outcomes such as low self-esteem, body image concerns, and mood disturbances, indicating its potential impact on mental health and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding self-directed stigma: development of the weight bias internalization scale. Durso, LE., Latner, JD.[2022]

A study of 942 Canadian adults found that weight bias internalization (WBI) is common across all body weight statuses, with higher scores in women and individuals with a BMI over 30, indicating a significant impact of societal attitudes on self-perception.

The majority of Canadians attribute obesity to behavioral factors, such as physical inactivity and overeating, which correlates with higher explicit weight bias, highlighting the need for public education on the multifaceted causes of obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight bias internalization and beliefs about the causes of obesity among the Canadian public. Forouhar, V., Edache, IY., Salas, XR., et al.[2023]

At least 44% of adults in the study reported mean levels of weight bias internalization (WBI), with the highest levels found in 52% of adults with obesity, indicating a significant prevalence of this issue across different populations.

Individuals with high WBI were more likely to be white, have lower education and income, be actively trying to lose weight, and have experienced previous weight stigma, highlighting the sociodemographic factors associated with internalized weight bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internalizing Weight Stigma: Prevalence and Sociodemographic Considerations in US Adults. Puhl, RM., Himmelstein, MS., Quinn, DM.[2022]

A study of 54 overweight and obese adults seeking weight loss treatment revealed significant levels of implicit, explicit, and internalized weight bias, which were linked to higher levels of depression, poorer body image, and increased binge eating.

While participation in weight loss treatment led to reductions in negative internalized and explicit weight bias, overall weight bias remained strong, suggesting that it may hinder individuals' ability to achieve optimal health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implicit, explicit, and internalized weight bias and psychosocial maladjustment among treatment-seeking adults. Carels, RA., Wott, CB., Young, KM., et al.[2022]

The Weight Bias Internalization Scale (WBIS) demonstrated strong psychometric properties in a study of 1,158 individuals with overweight and obesity, confirming its reliability and validity as a measure of internalized weight bias.

Higher WBIS scores were associated with increased depressive and somatoform symptoms, particularly among women, individuals with obesity, and those with lower education or income, highlighting the scale's relevance in understanding the psychological impact of weight bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight bias internalization scale: psychometric properties and population norms. Hilbert, A., Baldofski, S., Zenger, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6700514/

Weight bias internalization in a commercial ... The purpose of this study was to identify the prevalence and correlates of WBI in a large sample of adults in a commercial weight management programme.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352827321000306

Prevalence and correlates of weight bias internalization in ... Results showed higher mean WBIS-M scores among participants in the UK, Australia, and France than in Germany, the US, and Canada. Across all countries, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6103811/

Weight Bias Internalization and Health: A Systematic Review WBI is consistently associated with negative mental health outcomes such as depression, anxiety, poor self-esteem and body image, disordered eating, and ...

4. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-024-01132-7

Psychological interventions for internalized weight stigma This study conducted a systematic scoping review of existing literature on psychological interventions for internalized weight stigma (IWS).

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2018.02271/full

Weight Bias Internalization Among Adolescents Seeking ... Results: Adolescents expressed a high mean level of internalized weight bias (M = 5.45, SD = 0.88). Higher levels of internalization were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11906574/

Relationship Between Weight Bias Internalization and ... Weight bias internalization (WBI) negatively effects health outcomes in people with obesity. Little is known about how these experiences relate ...

7. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00959-w

The relationship between internalised weight bias and ... IWB demonstrates a mediational relationship [24, 25] between weight bias and adverse health outcomes (Fig. 1), with evidence highlighting a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06864208

Addressing Weight Bias Internalization to Improve ... WBI is associated with negative physical and mental health outcomes. The current study aims to test an intervention for weight stigma and WBI combined with an ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6636884/

Weight Bias Internalization and Long-Term Weight Loss in ... This study provides needed data pertaining to the relationship between WBI and weight loss. In a sample of patients who lost approximately 7 per ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/oby.22931

Six‐Month Follow‐up from a Randomized Controlled Trial ... The aim of this study was to investigate the 6-month nonintervention follow-up effects of a cognitive behavioral intervention for weight bias internalization ( ...